Prezista (Darunavir) Labeling Changes

On April 24, 2013, FDA approved revisions to the Prezista (darunavir) tablet and oral suspension label to update labeling with 48 week data from study TMC114-C228 for HIV-1 treatment experienced pediatric patients three to less than 6 years of age. The 48 week data is reflected in the Indications and Usage section and the following sections.

The proportion of subjects with HIV-1 RNA less than 50 copies/mL at Week 48 was 71%. The mean change in CD4+ percentage from baseline was 4%. The mean increase in CD4+ cell count from baseline was 187 x 106 cells/L.

Prezista is a human immunodeficiency virus (HIV-1) protease inhibitor indicated for the treatment of HIV-1 infection in adult patients. PREZISTA is also indicated for the treatment of HIV-1 infection in pediatric patients 3 years of age and older. PREZISTA must be co-administered with ritonavir (PREZISTA/ritonavir) and with other antiretroviral agents.

(Please note: Your name and comment will be public, and may even show up in Internet search results. Be careful when providing personal information! Beforeadding your comment, please read TheBody.com's Comment Policy.)

The Body is a service of Remedy Health Media, LLC, 750 3rd Avenue, 6th Floor, New York, NY 10017. The Body and its logos are trademarks of Remedy Health Media, LLC, and its subsidiaries, which owns the copyright of The Body's homepage, topic pages, page designs and HTML code. General Disclaimer: The Body is designed for educational purposes only and is not engaged in rendering medical advice or professional services. The information provided through The Body should not be used for diagnosing or treating a health problem or a disease. It is not a substitute for professional care. If you have or suspect you may have a health problem, consult your health care provider.